Epogen

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Discuss the risks and benefits of epoetin alfa with your doctor, as this medication may rarely cause very serious (possibly fatal) side effects, including blood clots, heart attack, stroke, or heart failure. It is very important to keep all lab appointments since your doctor will need to carefully check your red blood cell count and hemoglobin level. The lowest effective dose of this medication should be used.

When used to treat anemia related to cancer, this medication may also increase the risk of death and/or cause your tumor to grow faster. This medication should be stopped after completing a treatment course of chemotherapy as directed by your doctor.

Headache, body aches, cough, or injection site irritation/pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Epoetin alfa may sometimes cause or worsen high blood pressure, especially in patients with long-term kidney failure. This effect may be caused by the number of red blood cells increasing too quickly, usually within the first 3 months of starting treatment. If you have high blood pressure, it should be well controlled before beginning treatment with this medication. Your blood pressure should be checked often. Ask your doctor if you should learn how to check your own blood pressure. If high blood pressure develops or worsens, follow your doctor's instructions about diet changes and starting or adjusting your high blood pressure medication. Lowering high blood pressure helps prevent strokes, heart attacks, and further kidney problems. Keep all lab appointments to have your red blood cell count/hemoglobin level tested regularly to reduce the chance of this side effect.

Rarely, this medication may suddenly stop working well after a period of time because your body may make antibodies to it. A very serious anemia can result. Tell your doctor right away if symptoms of anemia return (such as increased tiredness, low energy, pale skin color, shortness of breath).

Tell your doctor right away if you have any serious side effects, including: symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).

Get medical help right away if you have any very serious side effects, including: seizures.

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). You may be at increased risk for blood clots if you are severely dehydrated, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, pregnant, or if you are immobile (such as on very long plane flights or being bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, if you have any of these conditions report them to your doctor or pharmacist. Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes, blood clots in your hemodialysis vascular access site.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using epoetin alfa, tell your doctor or pharmacist if you are allergic to it; or to any epoetin alfa products; or to other drugs that cause more red blood cells to be made (such as darbepoetin alfa); or if you have any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart disease (such as heart failure, past heart attack/stroke), seizure disorder, severe anemia caused by antibodies to past erythropoietin-type treatment (pure red cell aplasia).

Some forms of this medication are made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example, viruses such as hepatitis). Consult your doctor or pharmacist for more information.

This medication may contain phenylalanine. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid phenylalanine (or aspartame) in your diet, ask your doctor or pharmacist about using this medication safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, complete blood count that includes hemoglobin level) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Blood tests for your iron levels will also be done and you may be prescribed iron supplements to take. Your doctor may recommend that you eat a well-balanced diet rich in iron (such as raisins, figs, meat, eggs, vegetables, iron-fortified cereals). Follow your doctor's instructions and dietary recommendations.

If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store in the refrigerator. Do not freeze. Keep the medication in the original carton to protect from light. For the single-use vials, discard any unused medication right away. For the multi-use vials, store opened vials in the refrigerator and discard any unused medication after 3 weeks. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Read the Medication Guide and, if available, the Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given as an injection under the skin or into a vein as directed by your doctor, usually 1 to 3 times a week. Patients getting this medication before surgery may have a special dosing schedule. Hemodialysis patients should receive this medication by injection into a vein. If injecting this medication under the skin, the injection is given in the upper arms, abdomen, front of the middle thighs, or upper outer area of the buttocks. The dosage is based on your medical condition, weight, labs, and response to treatment.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Do not shake this medication. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. If you are injecting this medication under the skin, before each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is tender, red, bruised, hard, or has scars or stretch marks. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day(s) of the week as directed.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

It may take 2 to 6 weeks before your red blood cell count increases. Tell your doctor if your symptoms do not get better or if they get worse.